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Siemens Healthcare Diagnostics Inc - accessdata fda 2026

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The document is a 510(k) summary for the Dimension® HB1C Kit by Siemens Healthcare Diagnostics Inc., submitted to the FDA for premarket notification. It outlines the device's safety and effectiveness, intended use for measuring hemoglobin A1c in human blood to monitor diabetes, and its substantial equivalence to a legally marketed device. The kit includes reagent cartridges and calibrators, with detailed comparisons of technological characteristics and performance metrics against a predicate device.

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Click ‘Get Form’ to open the Siemens Healthcare Diagnostics Inc - accessdata fda document in the editor.
Begin by entering the assigned 510(k) number in the designated field. This is crucial for tracking and reference.
Fill in the Manufacturer's Name, Address, and Contact Information accurately. Ensure that all details match those provided in the document.
In the Device Name section, specify 'Dimension® HB1C Kit' as indicated. This helps identify the product clearly.
Complete the Device Intended Uses section by detailing its purpose for monitoring long-term glucose control in individuals with diabetes mellitus.
Review and compare technological characteristics against legally marketed devices to ensure compliance and accuracy.

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Who is the parent company of Siemens Healthcare diagnostics?

Siemens Healthineers AG (Siemens Healthineers), a subsidiary of Siemens AG, is a medical technology company that designs, develops, produces, and distributes diagnostic imaging systems, clinical and workflow systems and solutions, and systems for minimally invasive procedures.

Is Siemens Healthineers laying off?

ing to a company representative, the announcement is consistent with past reductions and part of a total 300 eliminated positions announced in November 2023. The layoffs are a result of Siemens Healthineers decision to stop production of certain instruments at its Morris County site.

What is the new name for Siemens Healthcare?

Siemens Healthineers In May 2016, the business operations of Siemens Healthcare were rebranded Siemens Healthineers. Globally, the companies owned by Siemens Healthineers have 65,000 employees. Siemens Healthineers - Wikipedia Wikipedia wiki SiemensHealthineers Wikipedia wiki SiemensHealthineers

Who is the largest shareholder of Siemens Healthineers?

Siemens Aktiengesellschaft You can see Siemens Healthineers historic earnings and revenue below, but keep in mind theres always more to the story. Siemens Healthineers is not owned by hedge funds. Our data shows that Siemens Aktiengesellschaft is the largest shareholder with 76% of shares outstanding. Public companies are Siemens Healthineers AGs (ETR:SHL yahoo.com news public-companies-sie yahoo.com news public-companies-sie

Is Siemens owned by Cerner?

On August 5, Cerner Corporation announced the acquisition of Siemens AGs Healthcare Information Technology business unit for $1.3 billion. Cerners Siemens Acquisition: What Does It Mean? ecgmc.com insights blog cerners-sieme ecgmc.com insights blog cerners-sieme

Is Siemens laying off employees?

Siemens Healthineers plans to lay off 300 workers amid a restructuring of the companys diagnostics business, ing to a filing last week with the New Jersey Department of Labor Workforce Development.

What is the Siemens Healthineers strategy 2025?

In 2020, Siemens Healthineers launched Innovation Hub in Bengaluru, India. The company plans to invest EUR160 million ($181.1 million) over the next five years as a part of its Strategy 2025. In addition, it plans to hire over 1,800 digital talents over the next ten years.

What does Siemens do in healthcare?

We bring clinical and workflow excellence to laboratories of any size with our testing systems, automation, and IT. And with our point-of-care testing systems, we deliver lab-accurate, actionable, and timely results on the spot.

Siemens Healthcare Diagnostics Inc - accessdata fda 2026

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